drugset / Trial / NCT04382664
UV1 Vaccination Plus Nivolumab and Ipilimumab in Treatment of Melanoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, open label study to investigate efficacy and safety of UV1 vaccination in combination with nivolumab and ipilimumab as first line treatment of adult patients with histologically confirmed unresectable metastatic melanoma.
Timeline
- Start
- 2020-05-27
- Primary completion
- 2024-01-11
- Completion
- 2024-04-10
Outcome
Missed primary endpoint
registry analysis (superiority test); UV1 Vaccination + Nivolumab and Ipilimumab vs Nivolumab and Ipilimumab; p = 0.845; Hazard Ratio (HR) 0.95 (80% CI 0.694 to 1.309); Regression, Cox NCT04382664 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | UV1 | Peptide | 300 ug | Other |
| Background | Ipilimumab | Monoclonal antibody | — | — |
| Background | Nivolumab | Monoclonal antibody | — | — |
| Background | sargramostim | Protein / enzyme biologic | 75 ug | — |